Code of Federal Regulations Title 45. Public Welfare § 45.1.6 Proper Department reliance on guidance documents

(1) The Department may not use guidance documents to impose binding requirements or prohibitions on persons outside the executive branch except as expressly authorized by law or as expressly incorporated into a contract.

(2) The Department may not treat noncompliance with a standard or practice announced solely in a guidance document as itself a violation of applicable statutes or regulations except as expressly authorized by law.

(3) If the Department uses a guidance document to explain the legal applicability of a statute or regulation, that document can do no more, with respect to prohibition of conduct, than articulate the Department's understanding of how a statute or regulation applies to particular circumstances.

(4) The Department may cite to a guidance document in a civil enforcement action only if it has notified the public of such document in advance through publication, in the Department's guidance repository, as described in § 1.4.